Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study

Abstract

Objective: Artificial Amnion and Placenta Technology (AAPT), designed to improve outcomes in extreme prematurity, has shown promise in animal studies, with human trials anticipated soon. This study seeks to inform the responsible design of future trials by utilising insights from parents who experienced an (imminent) extremely premature birth and perinatal healthcare professionals (HCPs). Design: A qualitative study using individual and focus group interviews. Setting: This study was part of a Dutch study called Toward Individualised care of the Youngest. Sample: Fifteen parents who experienced an (imminent) extremely premature birth and 46 HCPs were interviewed. Methods: Eight focus-group and five individual interviews were performed and transcribed. The transcripts were thematically analysed. Main Outcomes and Measures: The perspectives of HCPs and experienced parents on what they considered essential for human AAPT trials. Results: Analyses revealed some critical considerations represented in six themes: (1) optimise the animal model, (2) determine the goal of human trials, (3) carefully establish the research population, (4) formulate stop criteria, success criteria and outcome measures, (5) determine the role for parents during the AAPT trial, and (6) develop protocols for the trial and address logistical considerations. Conclusion: This study emphasises the critical role of stakeholder involvement in safeguarding the responsible design of human AAPT trials. Defining the trial objectives including well-defined stop criteria and follow-up schemes is a key element for the human AAPT trials. Establishing consensus among stakeholders is essential, as shared recommendations will facilitate alignment of expectations and promote engagement.